NCT00925639

Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Hypoestrogenism, common in menopause, is responsible for systemic and metabolic changes affecting women's wellness, favoring hot flashes, urogenital atrophy and bone mass loss. Hormone reposition therapy (HRT) with estrogen or estrogen associated to progesterone is administered to minimize these effects. Meanwhile, the beneficial effects of HRT are known, there is still concern about its adverse effects such as thromboembolic and cardiovascular effects, increased risk of breast and endometrial cancer. Thus, there is an increasing interest in the development of phytohormonal HRT. The aim of the investigators' study is to evaluate the effects of concentrated extract of soy on hypercoagulation markers in menopausal women.

Conditions

• Menopause

Interventions

Type	Name	Description
DRUG	Isoflavone	150 mg of concentrated extract of soy containing 60 mg of isoflavone comprising 40 mg of genistein, 14,55 mg of daidizein, 3,02 mg of daidzine, 1,14 mg of glicitine, 0,91 mg genistine and 0,38 mg of glicetein.
DRUG	Placebo	Starch pill

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-01-01
• Completion: 2010-08-01
• First posted: 2009-06-22
• Last updated: 2009-06-22

Locations

1 site across 1 country: Brazil